Study of Treatment Used for Migraine Headaches (MK-0974-076) (MASTER)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01421277
First received: July 28, 2011
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.


Condition
Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants on triptan therapy study entry [ Time Frame: At entry on study ] [ Designated as safety issue: No ]
  • Number of participants on triptan therapy at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants with migraine
Participants being treated by their Physicians for migraine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.

Criteria

Inclusion criteria:

  • At least 18 years of age in the United States at the time of consent
  • Physician-diagnosed migraine with or without aura
  • At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
  • Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
  • Used triptan medication at least once within 6 months prior to the date of informed consent for screening
  • Internet access and able to complete online surveys via electronic data entry

Exclusion criteria:

  • Treated with triptans prior to this study
  • In active litigation and compensation issues including disability dispute cases with a Government agency
  • Participation in a clinical trial within the last 90 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01421277     History of Changes
Other Study ID Numbers: MK-0974-076
Study First Received: July 28, 2011
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014